의료기기 보안 서비스 시장은 2025년에 120억 달러로 평가되었으며, 2026년에는 127억 6,000만 달러로 성장하여 CAGR 8.22%를 기록하며 2032년까지 208억 7,000만 달러에 달할 것으로 예측됩니다.
| 주요 시장 통계 | |
|---|---|
| 기준 연도 2025년 | 120억 달러 |
| 추정 연도 2026년 | 127억 6,000만 달러 |
| 예측 연도 2032년 | 208억 7,000만 달러 |
| CAGR(%) | 8.22% |
임상기술과 정보기술의 급속한 융합으로 의료기기의 보안 프로파일은 운영상의 문제에서 부서 간 거버넌스를 필요로 하는 전략적 위험으로 격상되었습니다. 커넥티드 케어, 소프트웨어 정의 기기, 통합 의료 생태계의 발전으로 공격 대상 영역이 확대되고, 벤더, 의료 시스템, 클라우드 제공자 간의 복잡한 종속 관계가 발생하고 있습니다. 따라서 임상공학, 정보 보안, 조달, 컴플라이언스 리더들은 제품 수명주기 전반에 걸쳐 환자의 안전, 데이터의 기밀성, 기기의 가용성을 보호하기 위해 협력해야 합니다.
의료기기 보안은 기술 혁신, 규제 진화, 위협 행위자의 행동 변화로 인해 변화하고 있습니다. 소프트웨어 정의 의료 시스템과 상호 운용 플랫폼의 보급은 새로운 의료 모델을 가능하게 하는 동시에 지속적인 모니터링과 적응형 방어가 필요한 복잡한 공격 벡터를 만들어내고 있습니다. 이와 함께 조정된 취약점 공개 프로그램의 성숙과 규제 당국의 기대치가 높아짐에 따라 제조업체와 서비스 제공업체는 설계 단계부터 보안 강화(Secure-by-Design)를 실천하고 투명한 수정 프로세스를 유지해야 한다는 압박을 받고 있습니다.
2025년 시행된 미국 관세 조정의 누적된 영향은 의료기기 생태계 전체에 파급되어 조달 전략, 공급업체 관계, 사업 계획에 변화를 가져왔습니다. 특정 수입 부품에 대한 관세 인상은 세계 공급망에 의존하는 제조업체의 투입 비용을 높이고, 대체 조달처 검토, 재고 버퍼 강화, 2차 공급업체 인증 가속화를 촉진하는 요인으로 작용했습니다. 이러한 공급 측면의 조정은 부품 교체 및 공급업체 변경으로 인해 예상치 못한 펌웨어 차이, 통합 문제, 호환성 위험, 추가 검증 및 보안 테스트가 필요하기 때문에 디바이스 보안 프로그램에 부차적인 영향을 미칠 수 있습니다.
세분화 분석을 통해 의료기기 보안 서비스에 대한 수요가 서비스의 성격, 도입 선택, 보안 도메인, 최종사용자 프로필, 기기 종류에 따라 어떻게 형성되는지 파악할 수 있습니다. 서비스 유형에 따라 조직이 개별 평가 또는 지속적인 운영 지원을 받을지 여부가 결정됩니다. 일부 고객들은 현재 위험을 파악하기 위한 컴플라이언스 평가와 보안 감사를 포함한 감사 및 평가 작업이 필요한 반면, 다른 고객들은 위험 평가와 전략적 사이버 보안 계획에 초점을 맞춘 컨설팅 서비스를 이용합니다. 통합 및 도입 작업은 구현 및 설정 프로젝트부터 의료기기의 원격 측정 데이터를 병원 IT 시스템과 연계하는 광범위한 시스템 통합까지 다양합니다. 한편, 매니지드 보안 서비스 계약은 지속적인 침해사고 대응, 모니터링 및 경보, 패치 관리, 취약점 관리를 제공하여 장기적인 복원력 유지를 도모합니다. 지원 및 유지보수 계약에는 일반적으로 소프트웨어 업데이트 및 기술 지원이 포함되며, 직원들의 기술 향상을 위해 온라인 모듈 및 현장 세션을 통한 교육 및 훈련 프로그램이 제공됩니다.
지역별 동향은 의료기기 보안 분야의 전략적 우선순위와 서비스 제공 모델에 큰 영향을 미칩니다. 아메리카 지역에서는 의료 제공자와 공급업체가 분산된 지불자 및 공급자 생태계, 엄격한 규제 모니터링, 고도의 위협 환경에 직면하고 있으며, 이로 인해 관리형 탐지, 사고 대응, 공급업체 책임 추궁에 대한 요구가 증가하고 있습니다. 북미 의료 시스템은 클라우드 기반 원격 측정 및 중앙 집중식 보안 운영을 선도적으로 도입하는 경향이 있으며, 조달팀은 공급업체에게 부품의 상세 출처 정보와 계약상의 보안 의무를 점점 더 많이 요구하고 있습니다.
의료기기 보안 분야의 경쟁 환경은 전문 사이버 보안 기업, 임상 분야 전문성을 갖춘 시스템 통합업체, 그리고 제공 모델에 보안 기능을 통합하는 경향이 강해지고 있는 의료기기 제조업체가 혼재되어 있는 특징을 가지고 있습니다. 전문 제공업체는 지속적인 취약점 관리, 기기별 사고 대응 플레이북, 임상 안전 목표에 따라 검증된 컴플라이언스 프레임워크 등 심도 있는 기술 제공으로 차별화를 꾀하고 있습니다. 시스템 통합업체와 매니지드 서비스 공급업체는 네트워크 및 클라우드 보안 관행과 디바이스 텔레메트리 통합, 대규모 의료 시스템을 위한 서비스 수준 보장을 결합하여 규모와 운영 연속성을 제공합니다.
업계 리더들은 거버넌스 강화, 운영 역량 가속화, 공급업체 책임 강화를 통해 디바이스 관련 리스크를 줄이기 위한 실행 가능한 행동 계획을 채택해야 합니다. 경영진은 임상공학, 사이버보안, 조달, 법무팀이 명확하게 정의된 역할과 디바이스 보안 사고의 에스컬레이션 경로로 연계된 부서 간 거버넌스 체계를 구축해야 합니다. 소프트웨어 부품표(SBOM) 공개, 패치 적용 일정, 협력적 취약점 공개(CVD)를 포함하는 보안 요구사항을 조달 계약에 포함시킴으로써 강제력 있는 기대치를 만들어 사고 발생 시 모호함을 줄일 수 있습니다.
본 Executive Summary를 뒷받침하는 설문조사는 정성적이고 구조화된 1차 조사와 선별된 2차 조사를 결합하여 실무자의 경험과 기술적 증거에 기반한 지식을 확보했습니다. 1차 조사에서는 임상 공학 리더, 최고 정보 보안 책임자, 의료기기 제조업체, 제3자 서비스 제공업체를 대상으로 인터뷰를 실시하여 실제 문제, 조달 요인, 시정 조치 사례를 파악했습니다. 이러한 인터뷰는 의료 환경에서 관찰되는 기기 통합 패턴, 펌웨어 업데이트 메커니즘, 일반적인 고장 모드에 대한 기술 검토를 통해 보완되었습니다.
결론적으로, 의료기기의 보안을 확보하기 위해서는 임상적 유용성을 유지하면서 사이버 리스크를 줄이고, 거버넌스, 기술적 통제, 공급업체 참여의 전략적 균형이 필요합니다. 소프트웨어 기반 장비의 확산, 복잡해지는 공급망, 진화하는 위협 행동의 수렴으로 인해 모니터링, 신속한 대응, 엄격한 변경 관리를 통합한 지속적이고 서비스 지향적인 보안 모델로의 우선순위 전환이 진행되고 있습니다. 조달, 임상 엔지니어링, 사이버 보안의 각 기능을 연계하는 조직은 공급업체의 책임성을 강화하고, 펌웨어와 부품의 출처를 확인하며, 의료를 방해하지 않고 적시에 패치를 적용하는 데 있어 더 유리한 위치에 서게 될 것입니다.
The Medical Device Security Service Market was valued at USD 12.00 billion in 2025 and is projected to grow to USD 12.76 billion in 2026, with a CAGR of 8.22%, reaching USD 20.87 billion by 2032.
| KEY MARKET STATISTICS | |
|---|---|
| Base Year [2025] | USD 12.00 billion |
| Estimated Year [2026] | USD 12.76 billion |
| Forecast Year [2032] | USD 20.87 billion |
| CAGR (%) | 8.22% |
The rapid convergence of clinical technology and information technology has elevated the security profile of medical devices from an operational concern to a strategic risk that demands cross-functional governance. Advances in connected care, software-defined devices, and integrated health ecosystems have increased attack surfaces and introduced complex dependencies between vendors, health systems, and cloud providers. Consequently, leaders in clinical engineering, information security, procurement, and compliance must coordinate to ensure that patient safety, data confidentiality, and device availability are protected throughout the product lifecycle.
This executive summary synthesizes the principal forces reshaping medical device security services, highlights structural shifts in procurement and deployment models, and frames the operational and regulatory implications that organizations must address. It draws on qualitative interviews with device manufacturers, health system security leaders, service providers, and regulatory guidance to illuminate practical levers for risk reduction. Throughout, emphasis is placed on aligning technical controls with governance, procurement, and clinical workflows so that security interventions strengthen resilience without disrupting care delivery.
As organizations evaluate security investments, they should prioritize approaches that enhance rapid detection and response, streamline secure configuration and patch management, and foster vendor accountability through service-level agreements and secure development practices. The remainder of this summary articulates the transformative landscape, tariff-related supply chain considerations, segmentation-driven service implications, and region-specific strategic priorities to inform executive decision-making.
Medical device security is undergoing transformative shifts driven by technological innovation, regulatory evolution, and changing threat actor behavior. The proliferation of software-defined medical systems and interoperable platforms is enabling new models of care but also creating complex attack vectors that require continuous monitoring and adaptive defenses. In parallel, the maturation of coordinated vulnerability disclosure programs and growing regulator expectations are increasing pressure on manufacturers and service providers to harden secure-by-design practices and maintain transparent remediation pathways.
Threat actors are also adapting; financially motivated criminal groups and opportunistic intruders increasingly target connected clinical endpoints to gain footholds for data exfiltration, ransomware, or disruption of clinical workflows. These trends are prompting health systems to shift from episodic, compliance-driven security activities to sustained, service-oriented models that emphasize rapid detection, incident response, and continuous risk assessment. Moreover, the escalation in supply chain complexity-where firmware, middleware, and cloud components originate from multiple vendors-has elevated third-party risk as a primary operational concern.
Consequently, security services are evolving beyond point-in-time audits to include integrated managed detection and response, proactive vulnerability management, and secure integration services that align with clinical and IT operations. As organizations adapt, there is increased demand for providers that can demonstrate cross-domain expertise, validated processes for patching and configuration management, and the ability to operationalize security controls without compromising clinical availability.
The cumulative impact of the United States tariff adjustments implemented in 2025 has reverberated across the medical device ecosystem, altering procurement strategies, supplier relationships, and operational planning. Increased duties on certain imported components have raised input costs for manufacturers who rely on global supply chains, incentivizing some organizations to examine alternative sourcing, increase inventory buffers, or accelerate qualification of secondary suppliers. These supply-side adjustments have secondary effects on device security programs because component substitutions and supplier changes can introduce unforeseen firmware variations, integration challenges, and compatibility risks that require additional validation and security testing.
Health systems and device integrators have responded by placing greater emphasis on supply chain transparency and on contractual provisions that obligate vendors to disclose component provenance, software bill of materials, and responsible disclosure practices. In many cases, procurement teams are incorporating security and provenance requirements into request-for-proposals and supplier onboarding checklists to mitigate the risk of unvetted components entering clinical environments. At the same time, some manufacturers have localized elements of production or increased qualification of regional partners to reduce tariff exposure, a move that can improve traceability but may necessitate renewed security validation across geographically distributed manufacturing footprints.
Operationally, these shifts have encouraged a closer collaboration between procurement, security, and clinical engineering to ensure that cost-driven sourcing decisions do not create gaps in patching, monitoring, or incident response capabilities. Organizations are adopting more rigorous change-control processes and supplier risk assessments to detect and remediate security implications early in the procurement lifecycle. Ultimately, the tariff environment of 2025 has reinforced the need for integrated resilience planning that accounts for both economic pressures and the technical rigor required to maintain secure, compliant medical device deployments.
Segmentation analysis reveals how demand for medical device security services is shaped by the nature of services, deployment choices, security domains, end-user profiles, and device classes. Service-type considerations drive whether organizations seek discrete assessments or ongoing operational support: some clients require audit and assessment work that includes compliance assessment or security audits to establish current-state risk, while others engage consulting services focused on risk assessment or strategic cybersecurity planning. Integration and deployment work ranges from implementation and configuration projects to broader system integration efforts that reconcile device telemetry with hospital IT systems. Meanwhile, managed security service engagements often provide continuous incident response, monitoring and alerting, patch management, and vulnerability management to maintain resilience over time. Support and maintenance contracts commonly cover software updates and technical support, and training and education programs are delivered through online modules or onsite sessions to elevate workforce competence.
Deployment mode influences architectural choices and operational responsibilities, with cloud-based options offering private or public cloud variations that reduce on-premise management overhead, hybrid arrangements combining integrated models or multi-cloud strategies to balance control and scalability, and on-premise models that remain self-managed or vendor-managed where local custody of sensitive workloads is required. Security type segmentation further refines service delivery: application security practices encompass dynamic and static application testing to find and remediate coding flaws; data security uses data loss prevention and encryption services to protect patient information; endpoint security leverages antivirus, anti-malware, and endpoint detection and response capabilities to secure clinical workstations and connected endpoints; identity and access management brings multi-factor authentication and single sign-on to bear on user controls; and network security relies on firewall services, intrusion detection and prevention, and network access control to defend communications.
End-user categories shape procurement cycles and service expectations: ambulatory care centers-both freestanding and specialty clinics-often favor lean, rapid-deployment solutions; diagnostic centers, whether pathology labs or radiology centers, prioritize throughput, data integrity, and integration with imaging and lab systems; hospitals, whether private or public, require scalable, redundant security operations and often balance cost constraints with regulatory obligations; and pharmacies, including hospital and retail outlets, emphasize transactional security, inventory system integrity, and secure dispensing workflows. Device-type distinctions drive technical requirements and testing regimes: diagnostic imaging devices such as CT and MRI need specialized integration and image integrity safeguards; implantable devices like defibrillators and pacemakers demand exceptionally rigorous firmware verification and lifecycle management; monitoring devices spanning remote patient monitoring and vital sign monitors require strong telemetry security and secure update mechanisms; and surgical equipment, from robotic surgical systems to surgical instruments, necessitates stringent safety-oriented security practices to ensure uninterrupted procedural availability and accurate device behavior.
Taken together, these segmentation layers inform how providers design offerings, prioritize investments, and demonstrate domain-specific competence to meet the nuanced needs of diverse clinical environments and device classes.
Regional dynamics materially inform strategic priorities and service delivery models across the medical device security landscape. In the Americas, healthcare providers and vendors contend with a fragmented payer and provider ecosystem, strong regulatory scrutiny, and a sophisticated threat environment that pushes demand for managed detection, incident response, and supplier accountability. North American health systems often lead in adopting cloud-based telemetry and centralized security operations, while procurement teams increasingly require detailed component provenance and contractual security obligations from suppliers.
Europe, the Middle East & Africa present a diverse regulatory and operational tapestry where harmonization efforts coexist with varied national requirements. European regulators' emphasis on patient safety and data protection has driven formalized vulnerability disclosure expectations and heightened scrutiny of device lifecycle responsibilities. In the Middle East and Africa, rapid digital health adoption in certain urban centers is accompanied by uneven security maturity, prompting opportunities for capacity-building, regional partnerships, and modular service offerings that address constrained local resources and differing infrastructure profiles.
Asia-Pacific features rapid adoption of connected care technologies combined with agile manufacturing capabilities and extensive regional supplier networks. Several markets in the region prioritize domestic production and localization, which can support traceability but may introduce variant firmware and integration profiles that necessitate expanded validation efforts. Across Asia-Pacific, there is considerable heterogeneity in regulatory regimes and security maturity, leading global vendors and local providers to adopt flexible service delivery models that range from full managed services to targeted advisory and integration projects.
Collectively, regional variations underline the importance of adaptable service portfolios, culturally informed engagement models, and the capacity to map regulatory obligations into operational controls that ensure secure, reliable device deployment within each jurisdiction.
Competitive dynamics in the medical device security space are characterized by a blend of specialized cybersecurity firms, system integrators with clinical domain expertise, and device manufacturers increasingly embedding security capability into their delivery models. Specialist providers differentiate through deep technical offerings such as continuous vulnerability management, device-focused incident response playbooks, and validated compliance frameworks that align with clinical safety goals. Systems integrators and managed service vendors bring scale and operational continuity, coupling network and cloud security practices with device telemetry integration and service-level commitments that appeal to larger health systems.
Device manufacturers are responding by strengthening secure development lifecycles, improving software bill of materials transparency, and collaborating with third-party security firms to support post-market monitoring and patch distribution. Strategic partnerships and channel arrangements are common as vendors seek to combine clinical domain competence with advanced security operations. Additionally, there is an observable trend toward vertical specialization where vendors concentrate on specific device classes-such as implantables, imaging systems, or monitoring devices-to offer tailored assurance services that reconcile clinical safety and cybersecurity requirements.
Market participants are investing in tooling, automation, and standardized processes to reduce time-to-detection and improve remediation efficiency. Those that can demonstrate repeatable, auditable processes for patch management, configuration baselining, and vendor coordination tend to gain traction with large health systems. Finally, service differentiation increasingly hinges on proof points: documented response times in clinical contexts, successful validation of secure integration projects, and evidence of collaborative relationships with manufacturers and regulatory bodies to speed vulnerability remediation without compromising patient care.
Industry leaders should adopt an actionable agenda that tightens governance, accelerates operational capabilities, and strengthens supplier accountability to reduce device-related risk. Executives must establish cross-functional governance structures that align clinical engineering, cybersecurity, procurement, and legal teams with clearly defined roles and escalation paths for device security incidents. Embedding security requirements into procurement contracts-covering software bill of materials disclosure, patch timelines, and coordinated vulnerability disclosure-will create enforceable expectations and reduce ambiguity during incidents.
Operationally, organizations should prioritize the deployment of continuous monitoring and rapid incident response capabilities that are tailored to medical device behavior. This includes integrating device telemetry into centralized security operations, formalizing playbooks for device isolation and clinical continuity, and exercising tabletop scenarios that involve clinicians, IT staff, and vendor support to validate response readiness. Leaders should also invest in structured patch management programs that reconcile clinical availability constraints with timely remediation, leveraging vendor-managed update mechanisms where appropriate to reduce operational burden.
From a supplier management perspective, cultivating strategic partnerships with vendors that demonstrate secure development practices and strong post-market support is essential. Where feasible, organizations should require evidence of secure-by-design processes and request participation in vulnerability disclosure programs. Finally, developing workforce capability through role-specific training-targeting clinical engineers, frontline IT staff, and procurement professionals-will sustain improvements by embedding security awareness and practical skills into daily operations. These steps, taken together, form a pragmatic roadmap to materially reduce exposure while preserving patient care continuity.
The research underpinning this executive summary combined qualitative and structured primary research with targeted secondary analysis to ensure findings are grounded in practitioner experience and technical evidence. Primary research included interviews with clinical engineering leaders, chief information security officers, device manufacturers, and third-party service providers to capture real-world challenges, procurement drivers, and remediation practices. These interviews were supplemented by technical reviews of device integration patterns, firmware update mechanisms, and typical failure modes observed in clinical environments.
Secondary analysis drew on publicly available regulatory guidance, standards, incident reports, and peer-reviewed literature to contextualize primary insights and validate themes such as secure development, supply chain provenance, and incident response best practices. Data triangulation techniques were applied to reconcile differing perspectives and to surface consistent patterns across stakeholder groups. Additionally, scenario analysis and case studies were developed to test how recommended interventions perform under constrained conditions, such as limited vendor support or high clinical demand.
Methodological rigor was further reinforced through iterative peer review and cross-validation of findings with domain experts. Limitations are acknowledged: the research emphasizes qualitative patterns and operational imperatives rather than quantitative market sizing, and some regional nuances may evolve as regulatory regimes and supplier behaviors change. Nevertheless, the combined methods provide robust, actionable insights intended to inform executive decision-making and operational planning.
In conclusion, securing medical devices requires a strategic balance of governance, technical control, and supplier engagement that preserves clinical availability while reducing cyber risk. The convergence of software-driven devices, complex supply chains, and evolving threat behavior has shifted priorities toward continuous, service-oriented security models that integrate monitoring, rapid response, and rigorous change control. Organizations that align procurement, clinical engineering, and cybersecurity functions will be better positioned to enforce supplier accountability, validate firmware and component provenance, and operationalize timely patching without disrupting care.
Regional and tariff-driven supply chain dynamics add layers of complexity but also create opportunities for improved traceability and localization strategies that can strengthen resilience when paired with rigorous validation and service-level commitments. Segmentation analysis underscores the need for tailored approaches: different device classes, deployment modes, and end-user profiles require distinct operational guardrails and service capabilities. Ultimately, the most effective responses will combine proactive supplier requirements, adaptive managed services, and workforce capability building to translate policy into sustained operational improvements.
Leaders should treat device security as an ongoing operational competency rather than a one-time compliance exercise. By embedding security into procurement, integrating device telemetry into enterprise operations, and investing in response readiness, organizations can materially reduce the likelihood and impact of security events while maintaining the continuity and quality of patient care.